Glepaglutide

Zealand Pharma's phase 3 trial of glepaglutide for short-bowel syndrome showed significant reduction in parenteral support volume at 24 weeks, with 66% of twice-weekly dosed patients responding clinically. Glepaglutide was safe, well-tolerated, and enabled some patients to achieve enteral autonomy. Further trials are planned.

The FDA issued a Complete Response Letter for Zealand Pharma's glepaglutide NDA, citing insufficient evidence for efficacy and safety. Zealand plans to continue dialogue with the FDA and proceed with a European Marketing Authorization Application in 2025. A new Phase 3 trial is expected to support global marketing authorizations and U.S. resubmission.

Zealand Pharma received a CRL from the FDA for glepaglutide's NDA, requiring an additional trial for SBS-IF treatment. Despite disappointment, Zealand remains confident in glepaglutide's efficacy and safety, planning a Phase 3 trial in 2025 for global approvals and a U.S. resubmission.

Zealand Pharma's shares fell after Jefferies lowered its price target due to the denial of approval for glepaglutide, a treatment for short bowel syndrome.

December 2024 FDA updates: Approved treatments include ustekinumab-kfce for inflammatory diseases, crinecerfont for CAH, nemolizumab for AD, and olezarsen for FCS. Notable actions: RMAT designation for rexlemestrocel-L, Boxed Warning for fezolinetant, and CRLs for glepaglutide and sotagliflozin. Pipeline updates: Tirzepatide outperformed semaglutide in weight loss, and novel therapies for HCV, PNH, and EoE showed promise.

December 2024 was active in gastroenterology with FDA news, pipeline updates, and new research. Highlights include Johnson & Johnson's sBLA for golimumab, Zealand Pharma's CRL for glepaglutide, and positive phase 2b data for duvakitug. GLP-1 RAs' impact on endoscopic procedures and new IBS research findings were also discussed.

The FDA made significant regulatory decisions, including the first drug approval for obstructive sleep apnea, a novel regenerative medicine for trauma patients, and treatments for rare diseases and cancer. Notable approvals include Eli Lilly’s Zepbound, Ionis Pharmaceuticals’ Tryngolza, and Humacyte’s Symvess. The FDA also expanded uses for existing drugs and issued rejections and warnings for others.

Zealand Pharma's GLP-2 drug, glepaglutide, for short bowel syndrome, failed FDA approval, requiring an additional trial. Despite phase 3 success, the FDA seeks further confirmation. Zealand plans to seek EMA approval in 2025 and continues discussions with the FDA.

Zealand Pharma announced the FDA issued a complete response letter for its NDA for glepaglutide, a GLP-2 analog for short bowel syndrome with intestinal failure. The FDA recommended an additional trial for efficacy and safety confirmation. Zealand Pharma remains committed to regulatory approval and plans a European MAA submission in 2025.

FDA issued a complete response letter to Zealand Pharma, stating the glepaglutide NDA for short bowel syndrome is not ready for approval and recommends an additional clinical trial. Zealand Pharma remains confident in glepaglutide's efficacy and safety, aiming to reduce parenteral support needs in SBS patients.